Cleared Traditional

STAT PROFILE CRITICAL CARE XPRESS ANALYZER

K022746 · Nova Biomedical Corp. · Chemistry
Nov 2002
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K022746 is an FDA 510(k) clearance for the STAT PROFILE CRITICAL CARE XPRESS ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on November 22, 2002, 95 days after receiving the submission on August 19, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K022746 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date November 22, 2002
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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